At-Home Neuromodulation for Female Sexual Dysfunction

Launched by UNIVERSITY OF MICHIGAN · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for women experiencing female sexual dysfunction (FSD) using a method called dorsal genital nerve stimulation (DGS). The goal is to see if women can successfully use this non-invasive device at home and if it can help improve symptoms related to sexual arousal. The study will involve both premenopausal and postmenopausal women who meet specific health criteria.

To participate, women must be able to speak and understand English and have a specific score on the Female Sexual Function Index, indicating they experience FSD. They should also be willing to follow the study's instructions and attend two sessions at Michigan Medicine, one at the beginning and one at the end of the study. However, women who are not currently sexually active, are pregnant, have certain medical conditions affecting their pelvic health, or have other specific exclusions will not be eligible. This study is not yet recruiting participants, but it aims to provide valuable insights into treating FSD and improving quality of life for women affected by this condition.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Capable of speaking and understanding English.
• • Able to comprehend the clinical study procedures and provide informed consent.
• • Identified as having female sexual dysfunction with a Female Sexual Function Index (FSFI) score of 26.55 or less and a score of 3 or less on one or more of the FSFI subdomains of lubrication, arousal, and orgasm.
• • Willing and able to adhere to the study protocol
• • Able to attend experimental sessions at Michigan Medicine at both the start and conclusion of the study.
• Exclusion Criteria:
• • Not currently sexually active.
• • Pregnant or planning to get pregnant during the study period.
• • History of a neurological disorder or impairments affecting pelvic organ function, including diagnosed with dorsal genital nerve damage, lower motor dysfunction, or other related conditions.
• • Implanted with a neurostimulator for bladder or bowel function.
• • Have a skin condition that would predispose them to sensitivity to the stimulation electrodes.
• • Female sexual dysfunction limited solely to low desire, without issues in lubrication, arousal, or orgasm.
• • Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms; or a score of 8 or higher on the American Urological Association Symptom Index (AUASI).
• • Unable or unwilling to adhere to the study protocol
• • Simultaneously participating in another research study that may affect the results of this study.